510(k) K100553
K100553 is an FDA 510(k) premarket notification submitted by Citizen Systems Japan Co., Ltd. for the device "BLOOD PRESSURE METER MODEL CH-101". The FDA issued a decision of Substantially Equivalent on May 25, 2010. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Citizen Systems Japan Co., Ltd. has 3 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2010
- Date Received
- Feb 26, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Measurement, Blood-Pressure, Non-Invasive
- Device Class
- Class II
- Regulation Number
- 870.1130
- Review Panel
- CV
- Submission Type
- 510(k)